Pharmalot
By Ed Silverman
July 22, 2010

For the past three years, the Chantix smoking cessation pill has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med (see this). The FDA subsequently imposed a risk management program and Pfizer added warnings.

Now, a new study in The Annals of Pharmacotherapy finds Chantix is not only associated with violent and agressive thoughts and acts, but has also identified some of the common characteristics among people using the pill and their subsequent behavior. The drug “does have warnings about psychiatric side effects, but it skims over aggression/violence towards others to focus mainly on suicidal behaviors,” says Thomas Moore, one of the co-authors and a senior scientist at the Institute for Safe Medication Practices, a non-profit that has issued reports previously about Chantix side effects.

“We believe this may be the first scientific report to examine the characteristics of aggression/violence as a psychiatric side effect for any prescription drug. What do these cases look like? A question answered for possibly the first time. We found the details striking and chilling. This is the first time we know of that aggression/violence has been clearly documented as a side effect in a peer reviewed scientific journal. This raises the question of whether (Chantix) is suitable for use in the military, by police and others who are already in stress situations. One key characteristic of these events is uncontrollable rage. Not a good side effect for people paid to carry guns.”

The researchers obtained 78 adverse event reports from the FDA MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; four more cases came from clinical trials, and three others came from published literature. Ultimately, they used 26 case reports for study and these described 10 events with assault, nine cases of homicidal ideation and seven instances of other thoughts or acts of aggression/violence. They noted that the patient population was predominantly middle-aged women, but “an unlikely age group and sex for assault and acts of violence toward others.”

“In all 26 cases,” they write, “the acts or thoughts of violence appeared to be inexplicable and unprovoked. A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car, with a young granddaughter also present. A 42-year-old man punched a stranger at a bowling alley. The stranger and two friends responded and knocked out the subject’s front teeth. A 24-year-old female started beating her boyfriend in bed because he “looked so peaceful” and she later attempted suicide. A 29-year-old female struck an acquaintance twice in the face, and then started smashing doors in her own home and beating on her truck.”

Read entire article:  http://www.pharmalot.com/2010/07/chantix-and-violence-what-patients-have-in-common/

*The package insert for Chantix shows that it contains a type of chemical compound that is better known as benzodiazepine—benzodiazepines are otherwise known as anti-anxiety drugs.